FDA recall Z-2237-2021

Product

Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS

Reason for recall

Due to high glucose test results when using the blood collection cards.

Distribution

U.S. Nationwide distribution in the states of MD and NC.

Key facts

Status

Terminated

Initiation date

2021-07-06

Report date

2021-08-18

Termination date

2023-08-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Scottsdale, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2237-2021